Vitamin K 1 Injection

Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Hospira, Inc. (2013-12-13)
Oldest Current Product
1983-07-25
License(s)
ANDA
RxNORM
INJECTION\VITAMIN K 1
FDAOB
INJECTION\INJECTION\PHYTONADIONE\rdfq
SPL Active
INTRAMUSCULAR\INJECTION, EMULSION\PHYTONADIONE
INTRAMUSCULAR\INJECTION, SOLUTION\PHYTONADIONE
SPL Moiety
INTRAMUSCULAR\INJECTION, EMULSION\PHYTONADIONE
INTRAMUSCULAR\INJECTION, SOLUTION\PHYTONADIONE

product(s) by strength(s)

1 ml vitamin k 1 10 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004099158ANDAHospira, Inc.1983-07-25PHYTONADIONEINTRAMUSCULARINJECTION, EMULSIONANDA087955e8808230-2c44-44c6-8cab-8f29b6b34051

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1525840158ANDAGeneral Injecatables & Vaccines, Inc2010-09-01PHYTONADIONEINTRAMUSCULARINJECTION, SOLUTION004099158ANDA087955ad54cca8-db8a-4cd7-aff9-464ccdda6950
2551542356ANDACardinal Health2011-08-24PHYTONADIONEINTRAMUSCULARINJECTION, EMULSION004099158ANDA0879551fc36ced-0e90-486b-b459-0414b7b9d0fb

0.5 ml vitamin k 1 2 mg/ml injection

generic product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1004099157ANDAHospira, Inc.1983-07-25PHYTONADIONEINTRAMUSCULARINJECTION, EMULSIONANDA087954e8808230-2c44-44c6-8cab-8f29b6b34051

relabeler product(s)(s)

#idcategorylabelerfirst marketedactive ingredient(s)routedose formequivalent productapplicationspl
1551542388ANDACardinal Health2011-08-24PHYTONADIONEINTRAMUSCULARINJECTION, EMULSION004099157ANDA0879541fc36ced-0e90-486b-b459-0414b7b9d0fb

application(s)

#idtitledeprecatedapplicantapprovedapproved drugin other drug docs
1ANDA083722PHYTONADIONEINTERNATIONAL MEDICATION SYSTEMANDA083722_001Vitamin K 1 Prefilled Syringe
2ANDA084060PHYTONADIONETrueGLAXOSMITHKLINEANDA084060_001, ANDA084060_002Vitamin K 1 Prefilled Syringe
3ANDA087954VITAMIN K1HOSPIRA INC1983-07-25ANDA087954_001Vitamin K 1 Prefilled Syringe
4ANDA087955VITAMIN K1HOSPIRA INC1983-07-25ANDA087955_001Vitamin K 1 Prefilled Syringe
5ANDA087956VITAMIN K1TrueHOSPIRA INC1983-07-25ANDA087956_001Vitamin K 1 Prefilled Syringe
6NDA011745KONAKIONTrueHOFFMANN LA ROCHE INCNDA011745_001, NDA011745_003Vitamin K 1 Prefilled Syringe
7NDA012223AQUAMEPHYTONTrueIGI LABORATORIES INCNDA012223_001, NDA012223_002Vitamin K 1 Prefilled Syringe

application drug(s)

#idcategory/deprecatedingredient strength(s)dose formrldTEapprovedapplication
1ANDA083722_001RXPHYTONADIONE (1MG/0.5ML)INJECTIONTrueBPPHYTONADIONE
2ANDA084060_001discontinuedPHYTONADIONE (1MG/0.5ML)INJECTIONFalsePHYTONADIONE
3ANDA084060_002discontinuedPHYTONADIONE (10MG/ML)INJECTIONFalsePHYTONADIONE
4ANDA087954_001RXPHYTONADIONE (1MG/0.5ML)INJECTIONTrueBP1983-07-25VITAMIN K1
5ANDA087955_001RXPHYTONADIONE (10MG/ML)INJECTIONTrue1983-07-25VITAMIN K1
6ANDA087956_001discontinuedPHYTONADIONE (10MG/ML)INJECTIONFalse1983-07-25VITAMIN K1
7NDA011745_001discontinuedPHYTONADIONE (1MG/0.5ML)INJECTIONFalseKONAKION
8NDA011745_003discontinuedPHYTONADIONE (10MG/ML)INJECTIONFalseKONAKION
9NDA012223_001discontinuedPHYTONADIONE (10MG/ML)INJECTIONFalseAQUAMEPHYTON
10NDA012223_002discontinuedPHYTONADIONE (1MG/0.5ML)INJECTIONFalseAQUAMEPHYTON

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
11fc36ced-0e90-486b-b459-0414b7b9d0fb (view SPL)VITAMIN K1 INJECTIONprescriptionHuman PrescriptionCardinal HealthREPACK2013-03-253551542356, 551542388
2ad54cca8-db8a-4cd7-aff9-464ccdda6950 (view SPL)Vitamin K1 Injection (Phytonadione Inj. Emulsion) 10 mg/mL USP 1 mL Single Dose AmpuleprescriptionHuman PrescriptionGeneral Injecatables & Vaccines, Inc2010-09-011525840158
3e8808230-2c44-44c6-8cab-8f29b6b34051 (view SPL)VITAMIN K1 INJECTIONprescriptionHuman PrescriptionHospira, Inc.2013-12-1312004099157, 004099158

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII